The U.S. Food and Drug Administration has issued guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. For more information, see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic.
NIH recognizes the significant effects that the COVID-19 emergency is having on NIH-funded clinical trials and other human subjects studies.
UF is temporarily closing access for in-person monitoring visits and scheduled meetings by clinical study sponsors.
While the university is requiring that all classes be moved online, there are currently no restrictions or limitations on research activities. Access to research facilities remains unchanged for faculty, staff, graduate students and others who are engaged in these activities.
New statement messages have been added to Research Statements to assist RBO staff as they follow up on aging research accounts.
When performing Epic Charge Reviews, be sure to review the descriptions of the services (in addition to CTP and EAP codes) when making bucketing determinations. These descriptions can help you verify that you are looking at the correct service(s) for your research participant.
Don’t forget to check your Epic InBasket! Study Teams can now review results for study-related orders from their Epic InBasket. When an order is research associated and resulted, an InBasket notification is sent to the Principal Investigator and all Study Coordinators listed on the Research Record in Epic as a CC’d…
Effective immediately: The existing guidance requiring the clinical research community to perform their Epic Research Billing Review (aka charge bucketing) within 7-days has changed. The new guidance requires that these reviews occur every 72-hours. The companion “Research Charges Awaiting Coordinator Review” reports have also increased in frequency to three-times per…